A Phase II Study of Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Inclusion Criteria:

- One of the following diagnoses with histological confirmation by the Pathology
Department at H. Lee Moffitt Cancer Center:

- Acute Lymphocytic Leukemia (ALL) in complete remission (CR) 1 with t(9:22) or
t(4:11), or any ALL beyond CR1

- Acute Myelogenous Leukemia (AML) with high risk cytogenetics in CR1 as defined by
Bloomfield any AML beyond CR1

- Myelodysplastic Syndrome (MDS) with IPSS score > 1

- Chronic myelomonocytic leukemia (CMML)

- Chronic Myelogenous Leukemia (CML) with Imatinib-refractory chronic phase, or beyond
chronic phase by morphology or cytogenetics

- Myelofibrosis

- Severe aplastic anemia

- Chemosensitive Non-Hodgkin's lymphoma and hodgkin's disease that are not candidate to
autologous transplant due to prior autologous transplantation

- Multiple Myeloma patient not candidate for autologous stem cell transplantation

- Karnofsky performance status ≥ 70% (adult)

- Normal organ and marrow function as defined below:

- Hepatic: Total bilirubin must be less than or equal to 2mg/dL (Gilbert and other
syndromes with increased indirect bilirubin are allowed); serum transaminases must be
less than two times the upper limit of normal

- Pulmonary: DLCO (corrected for Hgb), FEV1, FVC must be greater than 50% predicted

- Cardiac: Left ventricular ejection fraction at rest must be greater than 50%

- Renal: Creatinine clearance (measured or calculated) must be equal or greater than 50
ml/min/1.73m2

Exclusion Criteria:

- Anti thymocyte globulin (ATG) or anti T cell therapy in prior 45 days

- Splenectomized patients;

- A positive pregnancy test administered to all females of childbearing potential prior
to allogeneic stem cell transplant

- Inability to comply with follow up as determined by the patient's physician

- HIV-I/II infection prior to HSC transplantation, confirmed by NAT

- Uncontrolled bacterial or fungal infection

- History of documented invasive aspergillosis or CMV pneumonia

- Presence of any of the following comorbid conditions:

- History of myocardial infarction

- Congestive heart failure (even if symptomatically controlled)

- Peripheral vascular disease (including intermittent claudication or history of bypass
for arterial insufficiency)

- Untreated thoracic or abdominal aneurysm (6cm or more)

- History of any cerebrovascular accident including transient ischemic attacks

- Dementia

- History of peptic ulcer disease requiring treatment

- Connective tissue/rheumatologic disorders

- Diabetes unless being managed with dietary changes only

- Hemiplegia/paraplegia

- History of solid tumor excluding skin or cervical carcinoma after curative resection